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Approval Alert: Biogen/Eisai’s Leqembi® (lecanemab) Approved by NMPA to Treat Alzheimer’s Disease

Jan 9, 2024

Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration (NMPA) in China for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  Eisai has begun preparation for launch in Q3 2024.

On 22 December 2023, it was reported that Eisai will apply to the US FDA to expand approval for Leqembi® for prevention of AD as soon as April 2026.  Leqembi® was approved in Japan on 25 September 2023, and received traditional approval in the US on 6 July 2023.